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Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02141412
Recruitment Status : Completed
First Posted : May 19, 2014
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Marie Awad, American University of Beirut Medical Center

Brief Summary:
In a prospective randomized clinical trial involving adult patients undergoing elective surgery under general anesthesia, the investigators will enroll 216 patients, and evaluate 3 doses of prophylactic dexmedetomidine as a means to reduce postoperative shivering and quality of emergence from anesthesia versus placebo.

Condition or disease Intervention/treatment Phase
Anesthesia Recovery Anesthesia Emergence Shivering Postoperative Recovery Drug: dexmedetomidine 0.25 µg/kg IV Drug: dexmedetomidine 0.5 µg/kg IV Drug: dexmedetomidine 1 µg/kg IV Drug: Placebo Comparator Phase 4

Detailed Description:
Patients undergoing surgery under general anesthesia may experience several complications during the postoperative period. Shivering has been reported to occur in up to 65% of patients recovering from general anesthesia, and has been shown to cause detrimental effects to the patient. Previous studies have shown that dexmedetomidine 1µg/kg at the end of surgery significantly reduces the incidence of postoperative shivering and improves quality of emergence from anesthesia. However, this beneficial effect of dexmedetomidine is at the expense of prolonged time to extubation and awakening. The aim of this study is to find the optimal dose of dexmedetomidine that would be beneficial without delaying recovery from general anesthesia.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intravenous Dexmedetomidine For The Quaity Of Emergence From General Anesthesia: A Dose-Finding Study
Study Start Date : September 2009
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group I
Patients in Group I will receive dexmedetomidine 0.25 µg/kg IV (over 10 min) at closure of sevoflurane
Drug: dexmedetomidine 0.25 µg/kg IV
Active Comparator: Group II
Patients in Group II will receive dexmedetomidine 0.5 µg/kg IV (over 10 min) at closure of sevoflurane
Drug: dexmedetomidine 0.5 µg/kg IV
Active Comparator: Group III
Patients in Group III will receive dexmedetomidine 1 µg/kg IV (over 10 min) at closure of sevoflurane
Drug: dexmedetomidine 1 µg/kg IV
Placebo Comparator: Group IV
Patients in Group IV will receive same volume of normal saline at closure of sevoflurane
Drug: Placebo Comparator
Patients in Group IV will receive same volume of normal saline at closure of sevoflurane




Primary Outcome Measures :
  1. Postanaesthetic shivering incidence and score [ Time Frame: change from baseline every 10 minutes up to 1 hour post-operatively ]
  2. Quality of emergence from anesthesia [ Time Frame: Change from baseline every 5 minutes till extubation ]
    The anesthesiologist blinded to the group allocation will assess patients for coughing, hypertension, tachycardia, limb movement during extubation


Secondary Outcome Measures :
  1. Patient's Temperature [ Time Frame: every 10 minutes up to 1 hour post-operatively ]
  2. Time to extubation, awakening and orientation [ Time Frame: 1 hour post-operatively ]
  3. Sedation scores [ Time Frame: every 10 minutes up to 1 hour post-operatively ]
  4. Pain scores [ Time Frame: every 10 minutes up to 1 hour post-operatively ]
  5. Nausea and vomiting [ Time Frame: every 10 minutes up to 1 hour post-operatively ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-80 year-old
  • ASA class I, II, and III
  • patients undergoing elective surgery under general anesthesia with an estimated time of 1-3 h

Exclusion Criteria:

  • duration of surgery less than 1h or more than 3 h
  • allergy to dexmedetomidine
  • vasoactive antidepressant or analgesics
  • obesity (BMI>30)
  • fever
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141412


Locations
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Lebanon
American University of Beirut Medical Center
Beirut, Lebanon
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
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Principal Investigator: Marie Aouad, MD American Univesity of Beirut Medical Center

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Responsible Party: Dr. Marie Awad, Professor of Clinical Specialty, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT02141412    
Other Study ID Numbers: ANES.MA.10
First Posted: May 19, 2014    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Keywords provided by Dr. Marie Awad, American University of Beirut Medical Center:
optimal dose of dexmedetomidine
prevent shivering
improve quality of emergence
anesthesia
without delay
recovery
Additional relevant MeSH terms:
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Dexmedetomidine
Anesthetics
Anesthetics, Inhalation
Anesthetics, General
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors